Medicines/finished pharmaceutical products

Reference Number: 
TB299

Date of prequalification: 
11 July 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Linezolid
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 600mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/Alu 10x10; Bottle HDPE 20x1, 100x1
Applicant: 
Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India

API Manufacturing Site: 

(Linezolid) Symed Labs Ltd, Survey No 353, Domadugu (Village), Jinnaram (Mandal), Medak (Dist), Telangana, 502 313, India